Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00246909
First received: October 31, 2005
Last updated: May 4, 2012
Last verified: June 2011
  Purpose

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.

Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response of these parameters to treatment. Therefore, a questionnaire to assess GERD symptoms was developed (ReQuest TradeMark). An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect.

The aim of this study is to determine the minimal clinically important difference (MCID) in patients diagnosed with GERD. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be performed at the start of the study. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (8 weeks). During the first treatment week, the patients will receive either pantoprazole (tablet) or placebo once daily in the morning; for the following 7 treatment weeks all patients will receive pantoprazole. The study will provide further data on safety and tolerability of pantoprazole.


Condition Intervention Phase
Gastroesophageal Reflux
Drug: Pantoprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Determination of the Minimal Clinically Important Difference (MCID) of the Patient Orientated Self Assessment Scale ReQuest TradeMark in Patients Suffering From Endoscopically Confirmed Gastroesophageal Reflux Disease (GERD), Grade A-D According to Los Angeles Classification Treated With Pantoprazole 40 mg o.d. or Placebo o.d. Over One Week.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • ReQuest(tm) scores after one week of treatment.

Secondary Outcome Measures:
  • other symptom assessments
  • safety.

Estimated Enrollment: 600
Study Start Date: November 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main inclusion criteria:

  • In general good health other than gastroesophageal reflux disease (GERD)
  • History of GERD-related symptoms for at least 6 months prior to inclusion into the study
  • Endoscopically confirmed gastroesophageal reflux disease

Main exclusion criteria:

  • Acute peptic ulcer and/or ulcer complications
  • Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors on more than 3 consecutive days within the previous 28 days; except regular intake of acetylsalicylic acid in dosages up to 163 mg/day
  • Intake of Proton Pump Inhibitors and Histamine 2-receptor antagonists within the previous 14 days
  • Intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents
  • Pregnant or nursing female patients; Non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246909

  Show 51 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Hartmut Heinze, PhD Altana Pharma, D-78467 Konstanz, Germany
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00246909     History of Changes
Other Study ID Numbers: BY1023/M3-340
Study First Received: October 31, 2005
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Pantoprazole

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014